MAUDE Adverse Event Report: ALPHATEC SPINE INC PRE-CONTOURED / C.P. TI ROD 5.5 MM X 4 CM (CP TITANIUM - GRADE IV); PEDICLE SCREW SYSTEM

Model Number	73600-040
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Stenosis (2263); Osteolysis (2377)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A pedicle screw was removed during the revision case on (b)(6) 2016.Part number 73865-50; ti cannulated polyaxial screw 6.5 mm x 50 mm (ti-6ai-4v eli).An evaluation is not possible at this time.The implant(s) have not been returned nor has the identifying lot number(s) been provided.Upon the receipt of additional information and/or the suspect implant(s) a follow report will be submitted.
Event or Problem Description
Patient originally had l5/s1 synovial cystectomy in (b)(6) 2013.He went into the hospital with a complaint of severe back pain radiating to the left thigh and lower extremities.On (b)(6) 2015 an l5/s1 tlif was then performed in which alphatec instrumentation was utilized.The patient returned to the hospital on (b)(6) 2016 to perform a l3-l5 decompression and s1 bilateral screw revision.The patient had developed left-side low back pain with some claudication component.Ct myelography showed canal stenosis at the l3-l4 and l4-l5 in the setting of epidural lipomatosis.The patient also had osteolysis around the bilateral s1 screw.During the case, the intervening rod (l5/s1) was removed and found to be broken in two (2) discrete pieces.This had not been appreciated on the ct myelography images.Additionally, the epidural space was encountered and explored.The dorsal aspect of the peek interbody cage on the left side was identified.It appears to be solidly lodged into place and, thus, no additional manipulation or augmentation of the interbody fusion was felt to be indicated.

• Brand Name: PRE-CONTOURED / C.P. TI ROD 5.5 MM X 4 CM (CP TITANIUM - GRADE IV)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6558744
• Report Number: 2027467-2017-00029
• Device Sequence Number: 13476500
• Product Code: NKB
• UDI-Device Identifier: 00844856043497
• UDI-Public: 00844856043497
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 73600-040
• Device Catalogue Number: 73600-040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR