THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS DETAILED IN THE ARTICLE. EVENT DATES ARE MULTIPLE UNKNOWN DATES BETWEEN 2005 AND 2012. THIS REPORT IS FOR AN UNKNOWN SYNTHES ARCH LAMINOPLASTY SYSTEM AND UNKNOWN SYNTHES SCREWS /UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THERE ARE MULTIPLE UNKNOWN DATES OF IMPLANTATION. IT IS UNKNOWN IF OR WHEN DEVICES WERE EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THERE ARE MULTIPLE UNKNOWN CONCOMITANT THERAPY DATES BETWEEN 2005 AND AUGUST 2011. REPORTER POSTAL CODE AND PHONE NUMBER ARE UNKNOWN. 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, 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. (B)(4).
D
Patient 1
THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TUNG, KL. ET AL (2015), SINGLE-DOOR CERVICAL LAMINOPLASTY USING TITANIUM MINIPLATES ALONE, JOURNAL OF ORTHOPAEDIC SURGERY, VOL. 23 NO. 2, PAGES 174-179 ((B)(6)). THE PURPOSE OF THIS STUDY IS TO REVIEW THE RECORDS FOR THE OUTCOME OF 29 PATIENTS (20 MEN AND 9 WOMEN) WHO UNDERWENT SURGERY BETWEEN 2005 AND 2012. SURGERY INCLUDED SINGLE-DOOR CERVICAL LAMINOPLASTY FOR MYELOPATHY USING TITANIUM MINIPLATES FOR TREATMENT OF CERVICAL SPONDYLOTIC MYELOPATHY, OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT AND CENTRAL CORD SYSTEM. PATIENT AGES RANGED 35 TO 79 YEARS. PRIOR TO AUGUST 2011, 19 PATIENTS WERE IMPLANTED WITH A NON-SYNTHES 20-HOLE TITANIUM MINIPLATE; AFTER AUGUST 2011, 10 PATIENTS WERE IMPLANTED WITH AN UNKNOWN DEPUY SYNTHES PRE-CONTOURED ARCH LAMINOPLASTY SYSTEM. THE MEAN FOLLOW-UP WAS 4 YEARS, RANGING 2-9 YEARS. POSTOPERATIVELY, A SOFT NECK COLLAR WAS WORN FOR 2 WEEKS WITH NECK MOBILIZATION EXERCISES PERMITTED AS PAIN IMPROVED. THE AUTHORS DID NOT SPECIFY IF THE COMPLICATIONS EXPERIENCED WERE INVOLVING PATIENTS IMPLANTED WITH NON-SYNTHES MINIPLATES OR THE ARCH SYSTEM. THEREFORE, ALL COMPLICATIONS WILL BE REPORTED AS FOLLOWS FOR THE ARCH SYSTEM: HINGE NON-UNIONS IN 2 OF THE UNPLATED LAMINAE. SPRING BACK CLOSURE OCCURRED IN 5 OF THE UNPLATED LAMINAE, WITH A MEAN OF