UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS
Report
- Report Number
- 2939274-2021-01597
- Event Type
- Injury
- Date Received
- March 30, 2021
- Report Date
- March 3, 2021
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- KTT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: RING D., ET AL (1998) MONTEGGIA FRACTURES IN ADULTS, THE JOURNAL OF BONE AND JOINT SURGERY VOL. 80-A, NO. 12, PAGES 1-12, (USA). THIS STUDY AIMS TO DEFINE BETTER THE CIRCUMSTANCES AND PATTERNS OF INJURY AS WELL AS TO DOCUMENT THE RESULTS OF TREATMENT WITH CURRENT FIXATION TECHNIQUES OF TEN CONSECUTIVE YEARS OF EXPERIENCE WITH MONTEGGIA FRACTURES IN ADULTS. BETWEEN JANUARY 1985 AND DECEMBER 1994, FIFTY-ONE ADULTS WHO HAD A FRACTURE OF THE FOREARM AND DISLOCATION OF THE PROXIMAL RADIOULNAR JOINT (A MONTEGGIA FRACTURE) WERE MANAGED AT MASSACHUSETTS GENERAL HOSPITAL. 3 PATIENTS WERE EXCLUDED FROM THE STUDY. A TOTAL OF 48 PATIENTS (25 FEMALES, 23 MALES) WITH AVERAGE AGE OF FIFTY-TWO YEARS (RANGE, EIGHTEEN TO EIGHTY-EIGHT YEARS) WHOSE MEDICAL RECORDS AND RADIOGRAPHS AND FOLLOWED FOR AT LEAST 24 MONTHS WERE REVIEWED. THE FRACTURES WERE CLASSIFIED ACCORDING TO THE SYSTEM OF BADO. FOR BADO TYPE-I FRACTURE THERE WERE 7 PATIENTS (5 MALES, 2 FEMALES) WITH AN AVERAGE AGE OF 26 YEARS (RANGE, 18 TO 41 YEARS). THE ULNAR FRACTURE IN ALL SEVEN PATIENTS WAS FIXED WITH A 3.5-MILLIMETER DYNAMIC COMPRESSION PLATE. FOR BADO TYPE-II FRACTURES THERE WERE 38 PATIENTS (23 FEMALES, 15 MALES) WITH AN AVERAGE AGE OF 58 YEARS (RANGE, 27 TO 88 YEARS ). THREE ULNAR FRACTURES WERE FIXED WITH A TENSION BANDWIRE CONSTRUCT COMBINED WITH INTERFRAGMENTARY SCREWS. AN INTRAMEDULLARY STEINMANN PIN WAS USED FOR ONE. THE 34 FRACTURES WERE FIXED WITH A PLATE AND SCREWS: 27 FRACTURES WERE FIXED WITH A 3.5-MILLIMETER DYNAMIC COMPRESSION PLATE (17) OR A LIMITED-CONTACT DYNAMIC COMPRESSION PLATE (SYNTHES, PAOLI, PENNSYLVANIA), (10); TWO, A RECONSTRUCTION PLATE; FOUR, A SEMITUBULAR PLATE; AND ONE, A ONE-THIRD TUBULAR PLATE. FOR BADO TYPE-ILL , THERE WAS A (B)(6) OLD MAN. THE FRACTURE WAS TREATED WITH A DYNAMIC COMPRESSION PLATE. TWO MEN WHO HAD A BADO TYPE-IV FRACTURE WHO WERE (B)(6) YEARS OLD. THE FRACTURES WERE TREATED WITH STABLE ANATOMICAL FIXATION OF BOTH BONES OF THE FOREARM WITH 3.5-MILLIMETER DYNAMIC COMPRESSION PLATES. THE AVERAGE DURATION OF FOLLOW-UP WAS 6.5 YEARS (RANGE, TWO TO FOURTEEN YEARS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 5 PATIENTS DIED. FOUR PATIENTS DIED BEFORE THE TIME OF THE MOST RECENT FOLLOW-UP. FIGURE 4: A CASE OF A (B)(6) YEAR OLD MAN WHO SUSTAINED A BADO TYPE-II FRACTURE. TREATED WITH LIMITED-CONTACT DYNAMIC COMPRESSION PLATE WITH AN INTERFRAGMENTARY SCREW TO SECURE THE CORONOID PROCESS. THE FRACTURE OF THE RADIAL HEAD WAS REDUCED AND WAS FIXED WITH TWO SCREWS. RADIOGRAPHS, MADE FOUR YEARS AFTER THE INJURY SHOWS THAT THE RADIAL HEAD IS ENLARGED AND MISSHAPEN. (BADO TYPE-IV) A CASE OF A (B)(6) YEAR OLD, BOTH INITIALLY HAD AN UNSATISFACTORY RESULT. (BADO TYPE-IV) A CASE OF A (B)(6) YEAR OLD HAD DEVELOPED PROXIMAL RADIOULNAR SYNOSTOSIS. INITIALLY HAD AN UNSATISFACTORY RESULT. 1 PATIENT WITH BADO TYPE- II DEVELOPED PROXIMAL RADIOULNAR SYNOSTOSIS. NINE PATIENTS, ALL OF WHOM HAD A BADO TYPE-II FRACTURE, NEEDED A REOPERATION WITHIN THREE MONTHS AFTER THE INDEX OPERATION. ONE PATIENT HAD PERSISTENT INSTABILITY OF THE ULNOHUMERAL JOINT. THE PATIENT WHO HAD A BADO TYPE-II FRACTURE PROXIMALLY AND A GALEAZZI FRACTURE DISTALLY HAD PERSISTENT INSTABILITY OF THE DISTAL RADIOULNAR JOINT, WHICH WAS TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION OF A NONUNION OF THE ULNAR STYLOID PROCESS. ONE PATIENT HAD A TRANSIENT INCOMPLETE ULNAR NEUROPATHY POSTOPERATIVELY. SIX PATIENTS HAD ELECTIVE REMOVAL OF THE ULNAR PLATE, BUT NO LATE PROBLEMS RELATED TO THE HARDWARE WERE ENCOUNTERED. TWO HAD A FAIR RESULT, AND SIX HAD A POOR RESULT ACCORDING TO BROBERG AND MORREY. ALL EIGHT OF THE PATIENTS WHO HAD A FAIR OR POOR RESULT HAD RESTRICTED ULNOHUMERAL MOTION. TWENTYSIX PATIENTS HAD NO PAIN, FIFTEEN HAD MILD PAIN, SIX HAD MODERATE PAIN, AND ONE HAD SEVERE PAIN. 3 PATIENTS DEVELOPED PAINFUL OSTEOARTHROSIS. OF THE TWO UNSATISFACTORY RESULTS THAT WERE NOT ASSOCIATED WITH A FRACTURE OF THE CORONOID PROCESS, WAS DUE TO PAINFULLY RESTRICTED ROTATION OF THE FOREARM AFTER OPEN REDUCTION AND INTERNAL FIXATION OF A COMMINUTED FRACTURE OF THE RADIAL HEAD. TWO PATIENTS WHO HAD BEEN FOLLOWED RADIOGRAPHICALLY FOR LESS THAN FIVE YEARS HAD GRADE-I CHANGES; THESE WERE ALSO RELATED TO A MALUNION OF THE CORONOID PROCESS, AS DOCUMENTED FOUR YEARS POSTOPERATIVELY. COMPARTMENT SYNDROMET 3 FOR BADO TYPE I, 2 FOR BADO TYPE II. THE FIXATION WAS REVISED IN FIVE PATIENTS; FOUR HAD A POSTERIOR PLATE APPLIED, AND ONE HAD THE MEDIAL PLATE REAPPLIED. A PROXIMAL RADIOULNAR SYNOSTOSIS DEVELOPED IN THREE PATIENTS. NONE OF THE NEURAL INJURIES THAT OCCURRED AT THE TIME OF THE FRACTURE RESOLVED, AND ALL OF THE INVOLVED PATIENTS HAD A SUBSEQUENT RECONSTRUCTIVE TENDON TRANSFER. ONLY ONE PATIENT HAD SYMPTOMS REFERABLE TO PERSISTENT INSTABILITY. STRENGTH WAS DIMINISHED IN SEVEN PATIENTS. AN ULNAR MALUNION IN ONE PATIENT. IN ONE OF THESE PATIENTS AND IN TWO OTHERS, THE FRACTURE OF THE CORONOID PROCESS WAS NOT ANATOMICALLY REDUCED. ONLY TWO PATIENTS WERE MANAGED WITH IMMOBILIZATION OF THE LIMB FOR MORE THAN FOUR WEEKS. ONE HAD BADO TYPE-II FRACTURE THAT DISPLACED AFTER THE PLATE, WHICH HAD BEEN APPLIED TO THE LATERAL SURFACE OF THE ULNA, LOOSENED. LOOSENING OF ULNAR FIXATION 6 FOR BADO TYPE II. THE ULNAR FIXATION DEVICE LOOSENED AND THE FRACTURE BECAME MALALIGNED IN 6 PATIENTS, 5 PATIENTS (IN FIVE OF THESE PATIENTS THE ORIGINAL PLATE HAD BEEN APPLIED TO THE MEDIAL OR LATERAL SURFACE OF THE PROXIMAL ASPECT OF THE ULNA AND THE OLECRANON. THE FIXATION DEVICE LOOSENED IN BOTH THE PROXIMAL AND THE DISTAL FRAGMENT IN TWO PATIENTS AND IN ONLY THE PROXIMAL FRAGMENT IN FOUR. IN TWO PATIENTS WHO HAD A MASON TYPE-ILL FRACTURE OF THE RADIAL HEAD, A SECONDARY RESECTION OF THE RADIAL HEAD WAS PERFORMED. THIS WAS DONE IN ORDER TO ADDRESS COMBINED LOOSENING OF THE FIXATION DEVICE AND RESTRICTED ROTATION OF THE FOREARM DUE TO PROMINENCE OF THE IMPLANT IN TWO PATIENTS. IN TWO PATIENTS WHO HAD A MASON TYPE-ILL FRACTURE OF THE RADIAL HEAD, A SECONDARY RESECTION OF THE RADIAL HEAD WAS PERFORMED. THIS WAS DONE IN ORDER TO ADDRESS COMBINED LOOSENING OF THE FIXATION DEVICE AND RESTRICTED ROTATION OF THE FOREARM DUE TO PROMINENCE OF THE IMPLANT IN TWO PATIENTS. THIS REPORT IS FOR AN UNKNOWN SYNTHES 3.5-MILLIMETER DYNAMIC COMPRESSION PLATE AND 3.5-MILLIMETER LIMITED-CONTACT DYNAMIC COMPRESSION PLATE. THIS REPORT IS FOR ONE (1) UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS. THIS IS REPORT 1 OF 7 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487042 | UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS | APPLIANCE, FIXATION, NAIL | KTT | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |