LACTO SCR 2.0X7MM 2.0 SYS 2/PK
Report
- Report Number
- 0001032347-2021-00587
- Event Type
- Injury
- Date Received
- December 15, 2021
- Date of Event
- December 23, 2021
- Report Date
- April 28, 2022
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- JEY
- UDI-DI
- 00841036055028
- PMA / PMN Number
- K002083
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: L-PLT RT REG 2.0 LACTOSORB SYS; CAT# 915-2101; LOT# 181330. L-PLT LT REG 2.0 LACTOSORB SYS; CAT# 915-2102; LOT# 308570. QTY: 7 OF LACTO SCR 2.0X7MM 2.0 SYS 2/PK; CAT# 915-2301; LOT# 480430. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00582, 0001032347-2021-00583, 0001032347-2021-00584, 0001032347-2021-00585, 0001032347-2021-00586, 0001032347-2021-00588, 0001032347-2021-00589, 0001032347-2021-00590, 0001032347-2021-00591.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: L-PLT RT REG 2.0 LACTOSORB SYS; CAT# 915-2101; LOT# 181330. L-PLT LT REG 2.0 LACTOSORB SYS; CAT# 915-2102; LOT# 308570. QTY: 7 OF LACTO SCR 2.0X7MM 2.0 SYS 2/PK; CAT# 915-2301; LOT# 480430. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00582, 0001032347-2021-00583, 0001032347-2021-00584, 0001032347-2021-00585, 0001032347-2021-00586, 0001032347-2021-00588, 0001032347-2021-00589, 0001032347-2021-00590, 0001032347-2021-00591.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY. THE PATIENT HAS INDICATED FOR A REVISION, ALTHOUGH IT HAS YET TO OCCUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY DUE TO SWELLING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY. THE PATIENT HAS INDICATED FOR A REVISION, ALTHOUGH IT HAS YET TO OCCUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1906387 | LACTO SCR 2.0X7MM 2.0 SYS 2/PK | CRANIOFACIAL BONE SCREW, BIOABSORBABLE | JEY | BIOMET MICROFIXATION | NI | 480430 | 00841036055028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| R| H | SEE H10 |