MOTIVA IMPLANTS
Report
- Report Number
- 3012883202-2025-00397
- Event Type
- Injury
- Date Received
- February 21, 2025
- Date of Event
- December 10, 2024
- Report Date
- February 21, 2025
- Manufacturer
- ESTABLISHMENT LABS S.A.
- Product Code
- FTR
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AS STATED IN THE LITERATURE, ¿A NUMBER OF RISK FACTORS FOR RUPTURE HAVE BEEN IDENTIFIED; THE MOST COMMON CAUSE IS SURGICAL INSTRUMENT DAMAGE.¿ (HANDEL, GARCÍA AND WINXTROM, 2013. BREAST IMPLANT RUPTURE: CAUSES, INCIDENCE, CLINICAL IMPACT, AND MANAGEMENT. PLAST. RECONSTR. SURG. 132: 1128.) EARLY SEROMA FORMATION IS DEFINED AS PERIPROSTHETIC FLUID ACCUMULATION WITHIN THE FIRST POSTOPERATIVE YEAR, WHEREAS THE LATE FORM IS ANY MOMENT BEYOND THAT TIME.¿ (SFORZA, ET AL. 2017) ¿SEROMA CAN PRESENT BOTH EARLY AND LATE, WITH THE LATTER BEING RECENTLY LINKED WITH MALIGNANT GROWTHS AND PROLONGED ONSET.¿ (SFORZA, ET AL. 2017) SOME ANALYSES HAVE REVEALED THAT THE POCKET PLAYS A SIGNIFICANT ROLE IN DEVELOPING SEROMA, PATIENTS WITH SUBMAMMARY POCKET DEVELOPED SEROMA IN HIGHER RATES WHEN COMPARED WITH PATIENTS WITH SUBMUSCULAR POCKET. SUBMAMMARY POCKET INCREASES THE ODDS OF DEVELOPING SEROMA BY 7.5 TIMES. (SFORZA, ET AL. 2017) SOME FACTORS ARE SIGNIFICANTLY ASSOCIATED WITH SEROMA DEVELOPMENT: A HIGH BMI, LARGE IMPLANT SIZE, SUBMAMMARY POCKET, AND SMOKING WHICH SIGNIFICANTLY AMPLIFIED THE EFFECTS OF OTHER VARIABLES. (M. SFORZA, ET AL., 2017 UNRAVELING FACTORS INFLUENCING EARLY SEROMA FORMATION IN BREAST AUGMENTATION SURGERY. AESTHETIC SURGERY JOURNAL 2017, VOL 37(3) 301¿307 © 2016 THE AMERICAN SOCIETY FOR AESTHETIC PLASTIC SURGERY, INC. DOI: 10.1093/ASJ/SJW196 LARGER IMPLANT SIZE IS ALSO KNOWN TO BE RELATED TO HIGHER INCIDENCES OF OTHER COMPLICATIONS SUCH AS CAPSULAR CONTRACTURE AND HEMATOMA. (COLLINS JB, VERHEYDEN CN. INCIDENCE OF BREAST HEMATOMA AFTER PLACEMENT OF BREAST PROSTHESES. PLAST RECONSTR SURG.2012;129(3):413E-420E) PER OUR DIRECTIONS FOR USE, EACH PATIENT MUST RECEIVE THE ESTABLISHMENT LABS S.A. ¿MOTIVA IMPLANTS®: INFORMATION FOR THE PATIENT¿ DURING HER SURGICAL CONSULTATION, IT IS THE SURGEONS´ RESPONSIBILITY TO ENSURE THAT THE PATIENT COMPLETELY UNDERSTANDS THE INFORMATION REGARDING THE RISKS, BENEFITS, AND RECOMMENDATIONS ASSOCIATED WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY, AS WELL AS THE COMPLICATIONS TYPICAL OF ANY TYPE OF SURGERY. THIS DOCUMENT IS AVAILABLE IN MOTIVA® WEBSITE: IFU.MOTIVA.HEALTH ADDITIONALLY, THE REPORTED EVENTS ARE WELL-DOCUMENTED AND RECOGNIZED AS COMMON REASONS FOR COMPLAINTS. THESE EVENTS ARE CLEARLY DESCRIBED IN THE PRODUCT'S DIRECTIONS FOR USE (DFU) PROVIDED WITH THE IMPLANT, AS STATED ABOVE. ADDITIONALLY, NO CASES OF RUPTURE BECAUSE OF PRODUCT FAILURE HAVE BEEN REPORTED TO ESTABLISHMENT LABS EVER. PER OUR DIRECTIONS FOR USE, EACH PATIENT MUST RECEIVE THE ESTABLISHMENT LABS S.A. ¿MOTIVA IMPLANTS®: INFORMATION FOR THE PATIENT¿ DURING HER SURGICAL CONSULTATION, IT IS THE SURGEONS´ RESPONSIBILITY TO ENSURE THAT THE PATIENT COMPLETELY UNDERSTANDS THE INFORMATION REGARDING THE RISKS, BENEFITS, AND RECOMMENDATIONS ASSOCIATED WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY, AS WELL AS THE COMPLICATIONS TYPICAL OF ANY TYPE OF SURGERY. THIS DOCUMENT IS AVAILABLE IN MOTIVA® WEBSITE: IFU.MOTIVA.HEALTH THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED, TO DETERMINATE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: ¿BREAST IMPLANTS CAN POTENTIALLY REMAIN INTACT FOR DECADES IN THE BODY, BUT ALL SUCH DEVICES WILL FAIL AT SOME POINT. BREAST IMPLANTS RUPTURE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MOST LIKELY TO OCCUR; THE LONGER THE IMPLANT IS IN PLACE. THE FOLLOWING MAY CAUSE IMPLANTS TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS, IMPLANT STRESS, AND WEAKENING DURING IMPLANTATION, AGE AND DESIGN OF THE IMPLANT, SUBMUSCULAR RATHER THAN SUB-GLANDULAR LOCATION, THE OCCURRENCE OF POST-OPERATORY HEMATOMAS OR SEROMAS, FOLDING OR WRINKLING OF THE IMPLANT SHELL, EXCESSIVE FORCE TO THE CHEST, TRAUMA, COMPRESSION DURING MAMMOGRAPHIC IMAGING, AND SEVERE CAPSULAR CONTRACTURE¿. ESTABLISHMENT LABS REQUESTED THE UNIT TO CONFIRM THE EVENT AND TO PERFORM THE CORRESPONDING TESTING (INCLUDING BUT NOT LIMITED TO: REVISION AND CHARACTERIZATION UNDER THE MICROSCOPE OF THE RUPTURE SECTION, MECHANICAL TESTING ACCORDING TO APPROVED STANDARDS, ETC.). IT WAS INFORMED THAT THE PATIENT/DOCTOR HAS THE UNIT, AND IT IS PENDING TO CONFIRM IF IT CAN BE RETURNED. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES, AND IMPLANT RUPTURE IS A RISK ASSOCIATED WITH BREAST SURGERY, WHICH CAN OCCUR AT ANY TIME. SEROMA IS AN ACCUMULATION OF FLUID THAT RESULTS FROM TISSUE INFLAMMATION . THE ETIOLOGY OF SEROMA IS KNOWN IN BREAST SURGERY AND IS CONNECTED TO A HYPO VASCULAR MILIEU OR TRAUMA FOLLOWING THE SURGERY. OFTEN, SEROMAS ARE REABSORBED BY THE BODY OVER SEVERAL WEEKS, BUT NEEDLE DRAINAGE IS SOMETIMES NEEDED TO REMOVE THE FLUID8 . WHILE SEROMAS DO NOT INCREASE BREAST CANCER RISK, THEY SOMETIMES HEAL WITH SCAR TISSUE OR CALCIFICATIONS THAT CAN RAISE A CONCERN ABOUT MAMMOGRAMS IN THE FUTURE. SEROMA SYMPTOMS MOST OFTEN APPEAR A WEEK TO 10 DAYS AFTER SURGERY; THE AREA MAY FEEL TENDER AND SWOLLEN, WITH A DISCRETE LUMP AND REDNESS ARISING WITHIN A DAY OR TWO. EARLY SEROMA FORMATION IS DEFINED AS PERIPROSTHETIC FLUID ACCUMULATION WITHIN THE FIRST POSTOPERATIVE YEAR, WHEREAS THE LATE FORM IS ANY MOMENT BEYOND THAT TIME. INFECTION CAN OCCUR WITH ANY SURGERY OR IMPLANT. MOST INFECTIONS RESULTING FROM SURGERY APPEAR WITHIN A FEW DAYS TO WEEKS AFTER THE OPERATION5 . HOWEVER, INFECTION IS POSSIBLE AT ANY TIME AFTER SURGERY. IN ADDITION, BREAST AND NIPPLE PIERCING PROCEDURES MAY INCREASE THE POSSIBILITY OF INFECTION. INFECTIONS IN TISSUE WITH AN IMPLANT PRESENT ARE MORE CHALLENGING TO TREAT THAN INFECTIONS IN TISSUE WITHOUT AN IMPLANT PRESENT. IF AN INFECTION DOES NOT RESPOND TO ANTIBIOTICS, THE IMPLANT MAY HAVE TO BE REMOVED, WITH REPLACEMENT OCCURRING ONLY AFTER THE INFECTION IS RESOLVED. AS WITH OTHER SURGICAL PROCEDURES, TOXIC SHOCK SYNDROME (TSS), A LIFE-THREATENING CONDITION, HAS BEEN REPORTED IN RARE INSTANCES FOLLOWING BREAST IMPLANT SURGERY. TSS SYMPTOMS OCCUR SUDDENLY AND CAN INCLUDE HIGH FEVER (102° F/38.8° C OR HIGHER), VOMITING, DIARRHEA, FAINTING, DIZZINESS, AND/OR SUNBURN-LIKE RASH. PATIENTS SHOULD CONTACT THEIR DOCTOR IMMEDIATELY FOR DIAGNOSIS AND TREATMENT IF THEY EXPERIENCE THESE SYMPTOMS ANTERIOR/POSTERIOR ROTATION, ALSO CALLED FLIPPING, HAS BEEN OBSERVED MORE FREQUENTLY WITH COHESIVE GEL IMPLANTS. THE FLAT BASE OF THE IMPLANT IS POSITIONED ANTERIORLY, DEFORMING THE BREAST OF THE PATIENT. PROPER PLACEMENT AND POCKET DISSECTION REDUCE THE RISK OF OCCURRENCE15. FLIPPING CAN BE TREATED WITH BIMANUAL MANIPULATION IN THE OFFICE AND CAN BE DONE REPEATEDLY IN RECURRENT CASES. HOWEVER, IN SOME CASES, REVISION SURGERY MAY BE NECESSARY TO REDUCE POCKET DIMENSIONS. LITERATURE HAS REPORTED THAT THE INTERACTION BETWEEN BREAST ENVELOPES, THE IMPLANT'S PHYSICAL CHARACTERISTICS, AND POCKET DISSECTION COULD CAUSE MALPOSITION. OTHER THEORIES INCLUDE THE INVOLUTION OF BREAST TISSUE. REGARDING IMPLANT CHARACTERISTICS, FLIPPING HAS BEEN ASSOCIATED WITH THE PRESENCE OR ABSENCE OF TEXTURING IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS OF THIS DEVICE THAT WOULD HAVE CAUSED OR CONTIBUTED TO THIS INCIDENT. WHEN THE INVESTIGATION PROCESS IS COMPLETED, THE APPLICABLE FINDINGS WILL BE INCLUDED IN A SUPPLEMENTAL MEDWATCH. AT ESTABLISHMENT LABS, WE ARE COMMITTED TO PATIENT SAFETY AND CONTINUALLY EVALUATE THE PERFORMANCE OF OUR DEVICES THROUGH POSTMARKET SURVEILLANCE OF REPORTED COMPLAINTS & ADVERSE EVENTS. HAS CONTEXT MENU
THE SERIAL NUMBER PREVIOUSLY REPORTED WAS INCORRECT. THIS FOLLOW-UP SUBMISSION PROVIDES THE CORRECTED INFORMATION.
THE REPORTED DEVICE WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP BETWEEN THE REPORTED RUPTURE AND THE DEVICE. THE INITIAL VISUAL INSPECTION FOUND A DEVICE RUPTURE. MICROSCOPE INSPECTION SHOWED TRACE MARKS IN THE SHELL CONSISTENT WITH THOSE OF A SHARP INSTRUMENT REPRODUCED IN OUR LABORATORY, THIS IS DISTINCT FROM THE PATTERN RESULTING FROM A SPONTANEOUS TEAR IN THE SHELL OF THE IMPLANT. ELONGATION TESTS CONFIRMED THE SHELL COMPLIED WITH THE INTERNATIONAL SPECIFICATION STANDARDS. THE REPORTED INFECTION WAS CONFIRMED ACCORDING TO THE CLINICAL EVIDENCE PROVIDED. SEROMA AND ROTATION CANNOT BE CONFIRMED DUE TO LACK OF CLINICAL EVIDENCE. A COMPLETE REVIEW OF THE DHR FOR LOT 23051201 WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER AND STERILIZATION RUN FOUND NO OTHER SIMILAR COMPLAINTS REPORTED IN THE PAST. ¿ THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED, TO DETERMINATE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: RUPTURE ¿ BREAST IMPLANTS RUPTURE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION BUT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IN PLACE. THE FOLLOWING MAY CAUSE IMPLANTS TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS, IMPLANT STRESS AND WEAKENING DURING IMPLANTATION, IMPLANT AGE AND DESIGN, SUBMUSCULAR RATHER THAN SUBGLANDULAR LOCATION, THE OCCURRENCE OF POST-OPERATORY HEMATOMAS OR SEROMAS, FOLDING OR WRINKLING OF THE IMPLANT SHELL, EXCESSIVE FORCE TO THE CHEST, TRAUMA, COMPRESSION DURING MAMMOGRAPHIC IMAGING, AND SEVERE CAPSULAR CONTRACTURE. SILICONE GEL-FILLED IMPLANT RUPTURES ARE MOST OFTEN SILENT; THIS MEANS THAT MOST OF THE TIME, NEITHER THE DOCTOR NOR THE PATIENT CAN DETERMINE WITH THE PHYSICAL EXAMINATION IF THE IMPLANT HAS A TEAR OR HOLE IN THE SHELL. THE INTEGRITY OF BREAST IMPLANTS (AND DETECTION OF GEL FRACTURES AND/OR SILENT RUPTURES) CAN BE EVALUATED THROUGH SEVERAL TECHNIQUES. HIGH-RESOLUTION ULTRASOUND (HRUS) IS WIDELY ACCEPTED BY HEALTHCARE PROVIDERS AND PATIENTS FOR RUPTURE DIAGNOSIS. ADDITIONALLY, THE USFDA RECOMMENDS MAGNETIC RESONANCE IMAGING (MRI) SURVEILLANCE WITH THE FIRST MRI PERFORMED THREE YEARS POSTOPERATIVELY AND SUBSEQUENT MRIS PERFORMED EVERY TWO YEARS AFTER THAT. THESE RECOMMENDATIONS MAY VARY FROM COUNTRY TO COUNTRY, SO PLEASE PROVIDE THE PATIENT WITH ADDITIONAL GUIDANCE BASED ON YOUR COUNTRY'S CURRENT CARE STANDARDS. ESTABLISHMENT LABS DOES NOT RECOMMEND CLOSED CAPSULOTOMY FOR TREATING CAPSULAR CONTRACTURE BECAUSE IT CAN CAUSE IMPLANT RUPTURE. SOME SYMPTOMS MAY APPEAR, SUCH AS LUMPS SURROUNDING THE IMPLANT OR IN THE AXILLA, CHANGE OR LOSS OF SIZE OR SHAPE OF THE BREAST OR IMPLANT, PAIN, TINGLING, SWELLING, NUMBNESS, BURNING, OR HARDENING OF THE BREAST. THESE SYMPTOMS ARE NOT SPECIFIC TO RUPTURE AND MAY ALSO BE EXPERIENCED BY PATIENTS WHO HAVE CAPSULAR CONTRACTURE. SOME CASES HAVE BEEN REPORTED SUGGESTING THAT SILICONE-IMPLANT LEAKAGE SHOULD BE CONSIDERED IN THE DIFFERENTIAL DIAGNOSIS OF EOSINOPHILIA. INFECTION: ¿INFECTION CAN OCCUR WITH ANY SURGERY OR IMPLANT. MOST INFECTIONS RESULTING FROM SURGERY APPEAR WITHIN A FEW DAYS TO WEEKS AFTER THE OPERATION. HOWEVER, INFECTION IS POSSIBLE AT ANY TIME AFTER SURGERY. INFECTIONS IN TISSUE WITH AN IMPLANT PRESENT ARE HARDER TO TREAT THAN INFECTIONS IN TISSUE WITHOUT AN IMPLANT. IN THE CASE OF GLUTEAL AUGMENTATION WITH SILICONE FILLED IMPLANTS, SINCE THE ANUS IS ONLY 3 TO 4 CM FROM THE INCISION, IT IS RECOMMENDED TO STAPLE OR SUTURE A GAUZE SOAKED WITH POVIDONE-IODINE OVER THE ANUS DURING SURGERY. IF AN INFECTION DOES NOT RESPOND TO ANTIBIOTICS, THE IMPLANT MAY HAVE TO BE REMOVED, AND ANOTHER IMPLANT MAY BE PLACED AFTER THE INFECTION IS RESOLVED. AS WITH OTHER SURGICAL PROCEDURES, TOXIC SHOCK SYNDROME IN RARE INSTANCES HAS BEEN NOTED IN WOMEN AFTER GLUTEAL IMPLANT SURGERY. THIS IS A LIFE- THREATENING CONDITION AND ITS SYMPTOMS INCLUDE SUDDEN FEVER, VOMITING, DIARRHEA, FAINTING, DIZZINESS, AND/OR SUNBURN-LIKE RASH. PATIENTS SHOULD BE INSTRUCTED TO CONTACT THEIR DOCTOR IMMEDIATELY FOR DIAGNOSIS AND TREATMENT IF THEY HAVE THESE SYMPTOMS¿. SEROMA ¿ SEROMA IS AN ACCUMULATION OF FLUID THAT RESULTS FROM TISSUE INFLAMMATION. THE ETIOLOGY OF SEROMA IS KNOWN IN BREAST SURGERY AND IS CONNECTED TO A HYPOVASCULAR MILIEU OR TRAUMA FOLLOWING THE SURGERY. OFTEN, SEROMAS ARE REABSORBED BY THE BODY OVER SEVERAL WEEKS, BUT NEEDLE DRAINAGE IS SOMETIMES NEEDED TO REMOVE THE FLUID. WHILE SEROMAS DO NOT INCREASE BREAST CANCER RISK, THEY SOMETIMES HEAL WITH SCAR TISSUE OR CALCIFICATIONS THAT CAN RAISE A CONCERN ABOUT MAMMOGRAMS IN THE FUTURE. SEROMA SYMPTOMS MOST OFTEN APPEAR A WEEK TO 10 DAYS AFTER SURGERY; THE AREA MAY FEEL TENDER AND SWOLLEN, WITH A DISCRETE LUMP AND REDNESS ARISING WITHIN A DAY OR TWO. EARLY SEROMA FORMATION IS DEFINED AS PERIPROSTHETIC FLUID ACCUMULATION WITHIN THE FIRST POSTOPERATIVE YEAR, WHEREAS THE LATE FORM IS ANY MOMENT BEYOND THAT TIME. IN ADDITION TO CAUSING PAIN, A SEROMA INCREASES THE RISK OF DEVELOPING AN INFECTION IN THE BREAST. DEPENDING ON THE LOCATION, IT MAY ALSO INCREASE PRESSURE OVER THE SURGICAL SITE AND SOMETIMES CAUSE WOUND DEHISCENCE. ROTATION ¿ ANTERIOR/POSTERIOR ROTATION, ALSO CALLED FLIPPING, HAS BEEN OBSERVED MORE FREQUENTLY WITH COHESIVE GEL IMPLANTS. THE FLAT BASE OF THE IMPLANT IS POSITIONED ANTERIORLY, DEFORMING THE BREAST OF THE PATIENT. PROPER PLACEMENT AND POCKET DISSECTION REDUCE THE RISK OF OCCURRENCE15. FLIPPING CAN BE TREATED WITH BIMANUAL MANIPULATION IN THE OFFICE AND CAN BE DONE REPEATEDLY IN RECURRENT CASES. HOWEVER, IN SOME CASES, REVISION SURGERY MAY BE NECESSARY TO REDUCE POCKET DIMENSIONS. LITERATURE HAS REPORTED THAT THE INTERACTION BETWEEN BREAST ENVELOPES, THE IMPLANT'S PHYSICAL CHARACTERISTICS, AND POCKET DISSECTION COULD CAUSE MALPOSITION. OTHER THEORIES INCLUDE THE INVOLUTION OF BREAST TISSUE. REGARDING IMPLANT CHARACTERISTICS, FLIPPING HAS BEEN ASSOCIATED WITH THE PRESENCE OR ABSENCE OF TEXTURING, IMPLANT SHAPE/PROFILE, AND THE GEL-FILLING RATIO (I.E., TO WHAT DEGREE THE IMPLANT HAS BEEN FILLED). OTHER FACTORS SUCH AS INFECTION, HEMATOMA/SEROMA, CAPSULAR CONTRACTURE, DISSECTION, SURGEON¿S EXPERIENCE, PHYSICAL ACTIVITY, AND EXTERNAL MANIPULATION OF THE IMPLANT COULD POTENTIALLY CONTRIBUTE TO THE DEVELOPMENT OF THIS COMPLICATION. ¿ IN CONCLUSION, IT WAS DETERMINED THAT A PROBABLE CAUSE FOR THE RUPTURE REPORTED WAS A CUT RESULTING FROM A SHARP INSTRUMENT USED WHICH COULD HAVE WEAKENED THE SHELL. ¿ ¿ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS.
AUSTRALIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT OF BILATERAL BREAST IMPLANTS ON (B)(6) 2024. AT SEVEN WEEKS POSTOPERATIVELY, ON (B)(6) 2024, THE PATIENT PRESENTED TO THE CLINIC FOR EVALUATION DUE TO RIGHT BREAST PAIN AND SWELLING. UPON ASSESSMENT, THE PRESENCE OF AN INFECTION WAS IDENTIFIED, AND THE DECISION WAS MADE TO PROCEED WITH IMPLANT REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1512064 | MOTIVA IMPLANTS | ERGONOMIX ROUND SILKSURFACE WITH QID | FTR | ESTABLISHMENT LABS S.A. | 23051201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |